JP2023184533A - Prosthetic leaflet device - Google Patents

Abstract

To provide a heart valve repair device.SOLUTION: A heart valve repair device has: an atrial-fixation member having an expandable mesh configured to have an oval or circular shape in a deployed configuration, the atrial-fixation member comprising a central lumen; and a baffle extending from a portion of the atrial-fixation member. The baffle has: an anterior portion with a smooth atraumatic surface configured to coapt with at least a portion of one or more native leaflets of a native heart valve; and a posterior portion configured to engage and displace at least a portion of another native leaflet of the native heart valve. The baffle extends radially inward from the atrial-fixation member into the central lumen to approach a closed position of the displaced native leaflet.SELECTED DRAWING: Figure 2B

Description

TECHNICAL FIELD The present technology generally relates to implants for repairing regurgitating or incompetent heart valves and methods of implanting such implants. The technique is particularly useful for repairing regurgitating mitral valves.

[Reference to related applications]
This application incorporates the interests and priority of U.S. Provisional Patent Application No. 62/552,595, filed on August 31, 2017, and U.S. Provisional Patent Application No. 62/582,519, filed on November 7, 2017. These US Provisional Patent Applications are hereby incorporated by reference and incorporated herein in their entirety.

Examples of pathological conditions that adversely affect the proper functioning of the mitral valve include mitral regurgitation, mitral valve prolapse, and mitral stenosis. Mitral regurgitation is a heart disease in which the leaflets of the mitral valve do not come together and stick together at peak systolic pressure, resulting in abnormal leakage of blood from the left ventricle to the left atrium. There are many structural factors that can adversely affect proper closure of the mitral valve leaflets. For example, many patients suffering from heart disease develop dilatation of the heart muscle, resulting in enlargement of the mitral valve annulus. Enlargement of the mitral valve annulus makes it difficult for the leaflets to coapt during cardiac systole. Stretching or tearing of the chordae tendineae, the tendons that connect the papillary muscles to the underside of the mitral valve leaflets, may also adversely affect proper closure of the mitral valve annulus. For example, a rupture of the chordae tendinae may cause the valve leaflets to prolapse into the left atrium due to inappropriate tension on the leaflets. Abnormal regurgitation may also occur when papillary muscle performance is impaired, for example due to ischemia. When the left ventricle contracts during systole, the affected papillary muscles do not contract sufficiently to provide proper closure.

Mitral valve prolapse, or abnormal upward bulging of the mitral leaflets into the left atrium, causes irregular behavior of the mitral valve and can result in mitral regurgitation. may occur. The healthy functioning of the mitral valve may also be adversely affected by mitral stenosis or narrowing of the mitral orifice, which creates left ventricular filling impedance during cardiac diastole.

Typically, treatment of mitral regurgitation has required the administration of diuretics and/or vasodilators to reduce the amount of blood flowing back into the left atrium. Other procedures have been performed surgically (open and endovascular) to either repair or replace the mitral valve. For example, typical repair procedures involve cinching or excision of multiple portions of the dilated annulus.

Cinching of the valve annulus has generally been accomplished by implantation of an annular or circumferential ring that is secured to the valve annulus or surrounding tissue. Other repair techniques have also included suturing or clipping the leaflets into their mutual partial attachments.

Alternatively, a more invasive procedure has involved replacing the entire valve itself, where a mechanical valve or biological tissue is implanted in the heart to replace the mitral valve. These invasive procedures are traditionally performed through large open thoracotomies and are thus extremely painful, exhibiting considerable morbidity, and require long recovery periods.

However, many repair and replacement procedures may create additional problems for the patient as a result of instrument durability or improper dimensions of the annuloplasty ring or replacement valve. Additionally, many repair procedures are highly dependent on the skill of the cardiac surgeon, where poorly or inaccurately placed sutures can adversely affect the success of the procedure.

In addition to its irregular and unpredictable shape, the mitral valve annulus lacks significant radial support from surrounding tissue. Only the outer wall of the mitral valve is connected by muscle tissue. The inner wall of the mitral valve is bound by a thin vessel wall that separates the mitral annulus from the lower portion of the aortic outflow tract. As a result, significant radial forces at the mitral annulus cause collapse of the lower portion of the aortic tract, with potentially fatal consequences.

The left ventricular chordae tendineae may also pose an obstruction during deployment of mitral valve repair devices. The labyrinthine chordae tendineae within the left ventricle make navigating and positioning the deployment catheter extremely difficult during mitral valve repair.

Given the problems associated with current procedures, there continues to be a need for simple, effective, and less invasive devices and methods for treating dysfunctional heart valves.

A heart valve repair device is disclosed having an atrial fixation member with an expandable mesh configured to have an oval or circular shape in a deployed configuration, the atrial fixation member having a central The heart valve repair device comprising a lumen further includes a baffle extending from a portion of the atrial fixation member, the baffle being configured to mate with at least a portion of one or more native cusps of the native heart valve. and a posterior portion configured to at least partially engage and displace a portion of another native leaflet of the native heart valve. , a baffle extends radially inwardly from the atrial fixation member into the central lumen to approximate the closed position of the displaced native leaflet.

In the above-described devices, the baffle includes a strut configured in a basket having a hollow interior volume, the baffle extending from a portion of the atrial fixation member, and the baffle extending from one or more of the native cusps. a smooth atraumatic surface defining a coaptation surface for at least a portion, the baffle engaging and restraining at least a first portion of the functionally defective congenital leaflet; and a restraining portion configured to leave the second portion of the functionally defective congenital leaflet movable while the baffle is in a closed position with respect to the functionally defective leaflet. Extending radially inwardly into the central lumen for approximation.

The device of any one of the above, further comprising a plurality of friction elements provided on the plurality of portions of the atrial fixation member or baffle.

Device according to any one of the above, characterized in that the inner and outer sides of the atrial fixation member do not contain any frictional elements.

Any one of the above devices, wherein the baffle has a plurality of front struts and a plurality of rear struts, and a gap is provided between adjacent front struts and rear struts. .

Apparatus according to any one of the above, characterized in that it has a fabric covering that at least partially surrounds the baffle, and that the basket has a mouth that is not covered by the fabric.

Apparatus according to any one of the above, characterized in that it has a fabric covering at least partially surrounding the baffle, and the basket has a mouth covered by the fabric.

Device according to any one of the above, characterized in that the baffle consists of a biocompatible foam.

Apparatus according to any one of the above, characterized in that the front part of the baffle has a convex shape.

The posterior portion of the baffle is dimensioned and shaped to engage the central scallop of the three-scalloped natural mitral leaflet while leaving the remaining two scallops mobile. Any one of the above devices characterized by:

further comprising a first set of suture loops disposed circumferentially about the atrial fixation member, each suture loop of the first set having a lumen; a first suture disposed within the lumen of the suture loop and interconnecting adjacent suture loops, the diameter of the atrial fixation member being adjusted by tightening the first suture; Any one of the above devices characterized by:

further comprising a second set of suture loops disposed circumferentially about the baffle, each suture loop of the second set of suture loops having a lumen; a second suture disposed within the lumen of the suture loop and interconnecting adjacent suture loops, the diameter of the baffle being adjusted by tightening the second suture. any one of the above devices.

further comprising a third suture loop disposed in the baffle and a third suture disposed within the lumen of the third suture loop, wherein pulling the third suture displaces the baffle. The device according to any one of the above, characterized in that:

Any of the foregoing further comprising at least one fabric segment of the fabric attached to and at least partially spanning the atrial fixation member, wherein the fabric covering facilitates tissue ingrowth. A piece of equipment.

Any one of the above devices further comprising at least one fabric segment of fabric depending from the distal end of the atrial fixation member. The device may further include a biasing member attached to the at least one fabric segment and biasing the fabric segment away from the central lumen.

13. The device of any one of the preceding, further comprising a segment of fabric attached to the atrial fixation member, wherein the fabric covering facilitates tissue ingrowth.

Device according to any one of the above, characterized in that the atrial fixation member consists of at least two rows of cells.

The atrial fixation member further has a row of chevrons, at least two of the chevrons having through holes, and the atrial fixation member has a suture threaded through the through holes and tightening the suture. The device according to any one of the above, characterized in that the diameter of the atrial fixation member is adjusted by.

Device according to any one of the above, characterized in that the atrial fixation member has a frustoconical shape. The atrial fixation member may be configured to engage only the atrial wall. The size of the atrial fixation member, unconstrained by external forces, is greater than the size of the atrium during diastole. The repair device may be secured to the native heart valve only at the atrial fixation member and baffle.

Any one of the preceding devices, wherein the proximal end of the anterior side of the atrial fixation member is vertically offset from the proximal end of the posterior side of the atrial fixation member.

The atrial fixation member has an asymmetric shape and the length of the anterior side is greater than the posterior side of the atrial fixation member such that the anterior side of the atrial fixation member is vertically higher than the posterior side of the atrial fixation member. Any one of the above devices, characterized in that the length is longer than the length of the device.

Any one of the above devices, wherein the posterior side of the atrial fixation member is stiffer than the anterior side of the atrial fixation member. The atrial fixation member may have a plurality of interconnecting struts forming a plurality of cells, the struts on the posterior side of the atrial fixation member being thicker, wider and wider than the struts on the anterior side of the atrial fixation member. and/or the gap between adjacent struts is narrow.

Also disclosed is a method of repairing a regurgitant heart valve in a heart having an atrium with an atrial wall, a ventricle with a ventricular wall, a heart valve with at least two cusps having an open position and a closed position; the heart valve is disposed at the interface between the atrium and the ventricle, the heart has a valve annulus surrounding the heart valve, and the method includes providing a prosthetic valve leaflet device; The apical device has an atrial fixation member made of a stent-like material, the atrial fixation member having a central lumen configured to fluidly couple the atria and ventricles, and the atrial fixation member having an anterior portion, a posterior portion, having a proximal end, a distal end, a medial portion, and a lateral portion, the prosthetic valve leaflet device further includes a baffle depending from the distal end of the posterior portion of the atrial fixation member, and the anterior portion of the baffle. has a smooth atraumatic surface that acts as a new artificial interface for one of the two or more cusps, and the rear portion of the baffle has a the baffle protruding into the central lumen and proximate the closed position of the immobilized leaflet, the method comprising: implanting a leaflet device in the atrium such that the anterior, medial, and lateral portions of the atrial fixation member are spaced apart from the valve annulus; and positioning the holder to abut the holder.

In the above method, the atrial fixation member of the prosthetic valve leaflet device has at least two suture loops with eyelets, a suture strand threaded through the eyelets, and upon tightening the suture strand, the atrial fixation member collapses; The steps of implanting the leaflet prosthesis include tightening the suture strands to collapse the atrial fixation member, placing the leaflet prosthesis with the atrial fixation member collapsed within the atrium, and relaxing the leaflet prosthesis. and expanding the atrial fixation member into contact with the atrial wall.

In the above method, the prosthetic valve leaflet device may be secured to the heart valve only by the atrial anchoring member and the baffle.

Also disclosed is a heart valve repair device having an atrial fixation member with a central lumen and a baffle attached to the atrial fixation member, the baffle including at least one of the native heart valves. an anterior portion with a smooth atraumatic surface constituting an artificial coaptation surface configured to cohere with the two natural cusps and engage and constrain a portion of the functionally defective cusps; and a rear portion configured such that the baffle extends radially inwardly into the central lumen to approximate the closed position of the functionally defective leaflet. The device may further include a fabric covering at least partially surrounding the baffle. The baffle may be comprised of biocompatible foam. The device may further include a plurality of friction elements disposed on the rear portion of the semicircular ring and baffle. The baffle may form a basket with a hollow interior. The baffle may include a plurality of front struts and a plurality of rear struts, with gaps interposed between adjacent front struts and rear struts. The basket may have a mouth, the basket being covered by the fabric and the mouth of the basket being uncovered. The front portion of the baffle may have a convex shape. The rear portion of the baffle is dimensioned to engage the central scallop of the three-scalloped anterior or posterior mitral leaflet while leaving the remaining two scallops mobile. It is both decided and formed. Alternatively, the rear portion of the baffle is sized and shaped to engage the entire leaflet. The atrial fixation member may include a semicircular ring extending in a first plane, and the baffle extending in a second plane parallel to and perpendicularly offset from the first plane. There is. The front portion of the baffle is made of biocompatible foam. The atrial fixation member may include a semicircular ring sized to circumferentially surround the annulus between the anterolateral and posteromedial commissures.

Also disclosed is a heart valve repair device having an atrial fixation member with a central lumen and at least one fixation mechanism having a triangular anchor system and a posterior hook, the triangular anchor system having a partial ring. a first triangular extension attached to a first end of the partial ring and extending away from the baffle, a second triangular extension attached to a second end of the partial ring and extending away from the baffle; an atraumatic tip attached to the terminal end of the first and second triangular extensions, the posterior hook attached to the posterior portion of the atrial fixation member, and the posterior hook distally attached to the posterior portion of the atrial fixation member. the device has an extending first portion and a second portion curved in a posterior direction, the posterior hook configured to extend into the ventricle to engage the ventricular side of the native heart valve annulus; further comprising a baffle attached to the partial ring, the baffle having an anterior portion with a smooth atraumatic surface constituting an artificial interface for the one or more natural cusps, and a functional the baffle has a rearward portion configured to engage and displace at least a portion of the defective leaflet, the baffle extending into the central lumen and proximate a closed position for the displaced leaflet.

The above device further comprising a fabric covering at least partially surrounding the baffle. The above device, wherein the baffle is made of biocompatible foam. The device further comprises a plurality of friction elements disposed on the atrial fixation member and the rear portion of the baffle. For any of the above devices, the baffle may be a basket with a hollow interior. The baffle may include a plurality of front struts and a plurality of rear struts, with gaps interposed between adjacent front struts and rear struts. The basket has a mouth, the basket is covered by fabric, and the basket mouth is uncovered.

For any of the above devices, the front portion of the baffle may have a convex shape. The rear portion of the baffle engages and immobilizes the central scallop of the three-scalloped anterior or posterior mitral leaflet while movable the remaining two scallops. It is sized and shaped to remain in its original condition. The rear portion of the baffle is sized and shaped to engage the entire leaflet. The atrial fixation member has a semicircular ring sized to circumferentially surround the heart valve annulus between the anterolateral and posteromedial commissures.

A heart valve repair device is disclosed having an atrial fixation member with a central lumen and a baffle attached to the atrial fixation member, the baffle engaging one or more native cusps. an anterior portion with a smooth atraumatic surface constituting an artificial joint surface shaped to mate and configured to engage and displace at least a portion of the functionally defective leaflet; With a rearward portion, the baffle extends into the central lumen and approaches a closed position for the functionally defective leaflet.

The above-described device further includes a fabric covering at least partially surrounding the baffle. The baffle is made of biocompatible foam. The device further includes a plurality of frictional engagement elements disposed on the atrial fixation device and the rear portion of the baffle. The baffle may be a basket with a hollow interior. The baffle has a plurality of front struts and a plurality of rear struts, and gaps are provided between adjacent front struts and rear struts. The basket has a mouth, the basket is covered by fabric, and the basket mouth is uncovered.

Device as described above, characterized in that the front part of the baffle has a convex shape. The rear portion of the baffle engages and displaces the central scallop of the three-scalloped anterior or posterior mitral leaflet while leaving the remaining two scallops movable. It is sized and shaped to remain as it is. The atrial fixation member includes a partially circular frusto-conical member having first and second ends and a brace extending between the first and second ends of the atrial fixation member. has.

Any of the devices described above further comprises at least one fixation mechanism selected from the group (triangular anchor and posterior hook), the triangular anchor attached to the first end of the atrial fixation member. a first triangular extension attached to the second end of the atrial fixation member and extending away from the baffle; and an anchor and the first and second triangular extensions. an atraumatic tip attached to the distal end of the atraumatic tip;

Also disclosed is a heart valve repair device for repairing a mitral valve having an anterior leaflet and a posterior leaflet, the device having an atrial fixation member configured to have a collapsed configuration and an expanded configuration; The member has an expandable ring-shaped mesh, the atrial fixation member is configured to contact tissue of the atrial wall upstream of the native annulus, and the device is configured to extend radially inwardly from the atrial fixation member. further comprising a baffle extending into the ventricle, the baffle having an outer portion configured to displace the posterior leaflet toward the ventricular wall and restrain the posterior leaflet in an open position, and an abutment surface radially inwardly of the outer portion. and an inner portion spaced apart from the outer portion by a distance such that the articular surface is positioned at least near the closed position of the anterior leaflet. The atrial fixation member may be configured to only contact atrial wall tissue above the native annulus. The heart valve repair device may further include a biocompatible coating disposed on a surface of the baffle. The baffle has a posterior strut extending in a downstream direction from the atrial fixation member and a anterior strut projecting inwardly and upwardly from the downstream end of the posterior strut, and a heart valve repair device is attached to the posterior and anterior struts. It further has a coating. The atrial fixation member can include a plurality of struts, and the heart valve repair device further includes a covering attached to the struts of the atrial fixation member.

FIG. 2 is a schematic diagram of the mitral valve. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG. 1 is a diagram of a prosthetic valve leaflet device according to an embodiment of the present technology; FIG.

Various embodiments are disclosed for addressing regurgitant or dysfunctional heart valves, including, but not limited to, the mitral valve. Several embodiments of prosthetic leaflet devices are disclosed, all of which displace at least a portion of at least one leaflet and provide an atraumatic artificial coaptation surface for the remaining leaflets. share a common theme. The artificial articulation surface does not move like a natural cusp in that it does not shift between open and closed positions. Alternatively, an artificial coaptation surface can be fixed in place with the closed position of a partially or fully displaced natural cusp, or such an artificial coaptation surface can have limited movement that mimics or approximates this. has. Some embodiments of valve repair devices are described herein with reference to the mitral valve, with the understanding that the utility of the technology is not limited to the mitral valve and can be used with other heart valves. do.

In the context of the mitral valve, embodiments of the present technology displace and at least partially displace a portion of one of the leaflets while providing an atraumatic articulation surface for the other natural leaflet. Good to be used for. Embodiments of the present technology displace the natural cusp with an implant that occludes approximately the same area as the fully closed natural cusp during displacement. The new articular surface mimics or approaches the closed position of the natural leaflet. Referring to FIG. 1, which shows the natural mitral valve, the anterior and posterior leaflets of the mitral valve each have three well-defined scallops (A1-A3 and P1-P3). Some of the embodiments disclosed herein may allow only one or two of the leaflet scallops to be displaced and immobilized, while the remaining leaflet scallops remain intact and mobile. However, other embodiments allow the entire leaflet (i.e., all three scallops) to be displaced and immobilized, while leaving the opposing leaflet intact and mobile. I'll keep it. For simplicity of explanation, some aspects of the present technique will be described by displacing and immobilizing the posterior leaflet of the mitral valve while providing an atraumatic coaptation surface for the anterior leaflet. However, the present technique can also be used to displace and immobilize the anterior leaflet while providing an atraumatic interface for the posterior leaflet.

Still referring to FIG. 1, the mitral valve has an anterior leaflet and a posterior leaflet. The anterior leaflet has a semicircular shape and extends 2/5 of the circumference of the annular. Movement of the anterior leaflet defines the boundary between left ventricular inflow (diastole) and outflow (systole). The posterior leaflet of the mitral valve is crescent-shaped and extends approximately three-fifths of the way around the annulus. The posterior leaflet typically has two clearly defined scallops that divide the leaflet into three individual scallops identified as P1 (anterior or lateral scallop), P2 (medial scallop), and P3 (posterior or medial scallop). It has a concave dent. The three corresponding segments of the anterior leaflet are A1 (anterior segment), A2 (medial segment), and A3 (posterior segment). The apex recess helps the posterior recess open during diastole.

The mitral valve has anterolateral and posteromedial commissures that define well-defined areas where the anterior and posterior leaflets meet in the annulus. These commissures can exist as well-defined apical segments, but often this region is defined by two anatomical landmarks: (a) the axis of the corresponding papillary muscle, and (b ) is a fine structure that can be identified using commissural chordae with a specific fan-like morphology. Several millimeters of valvular tissue separate the free edge of the commissure from the annulus.

The mitral valve is an atrioventricular valve that fluidly couples the left atrium to the left ventricle. The mitral valve annulus defines the anatomical junction of the left ventricle and left atrium. The fixed end of the leaflet rests on the annulus. The anterior portion of the mitral annulus is attached to the fibrous trigone and is generally more expanded than the posterior annulus. The right fibrous triangle is a region of dense junction between the mitral, tricuspid, and non-coronary leaflets of the aortic annulus and membranous septum. The left fibrous triangle is located both at the left fibrous border of the aorta and at the junction of the mitral valve.

The mitral annulus is not very well developed at the insertion site of the posterior leaflet, as this segment is not attached to any fibrous structures and the fibrous annulus in this region is This is because the shaped skeleton is discontinuous. The circumference of the posterior portion of the valve annulus increases, which may cause mitral regurgitation in conjunction with left atrial or left ventricular dilatation. The mitral valve annulus is saddle-shaped, and during cardiac systole, the commissural region moves toward the atrium to make it flatter, while the annulus also narrows around this. Both processes aid apical coaptation, and both processes can be adversely affected by processes such as annular dilatation and calcification. The mitral annulus is surrounded by several important anatomical structures including the aortic valve, coronary sinus, and circumflex artery.

2A-2E illustrate a valve repair device according to the present invention. The valve repair device may be a prosthetic leaflet device 100 that includes an atrial fixation member 102 and a baffle 114 depending in a downstream direction from the atrial fixation member 102. The atrial fixation member 102 may be configured to help position and hold the baffle 114 in a desired location relative to the natural valve anatomy, with the baffle 114 positioned at the natural leaflet of the valve. It is configured to displace at least a portion to create an artificial coaptation surface for at least a portion of one or more of the other leaflets of the native valve at the location provided by the atrial fixation member 102. For example, the baffle 114 is configured to displace a functionally defective natural leaflet, such as a posterior leaflet that has degenerated, dehisced, fluttered, or otherwise no longer closes effectively during cardiac systole. It's good to be there. In valves with dilated annuluses such that regurgitation occurs between two native cusps that are no longer effectively coaptating, the baffle 114 may extend beyond the dimensions of the existing cusps to effectively connect the other cusps. A proper bond can be re-established.

Atrial fixation member 102 may be formed of a mesh, such as a braid or stent-like structure, including a plurality of interconnecting wires or struts 104 that cooperate to form a plurality of cells. It will be done. Atrial fixation member 102 helps hold baffle 114 in place by engaging the wall of the left atrium, and may have a generally frustoconical shape. Each cell of atrial fixation member 102 defines an opening or through-hole 106. The unconstrained shape of the atrial fixation member 102 may be generally circular or oval. The atrial fixation member 102 includes any number of through holes 106 or any shape or size such that the atrial fixation member 102 contacts the left atrial wall with at least a threshold amount of radial force to stabilize the position of the baffle 114. It is good to have The radial force can be adjusted by varying the shape and dimensions of the struts (thickness, width, and spacing between struts) and the shape and dimensions of the through holes 106. For example, wider and/or thicker struts 104 can increase compression resistance, while larger openings or through holes 106 and/or thinner struts 104 can increase compression resistance. Reduce resistance. These concepts are explained in more detail below. In FIG. 2A, opening 106 is generally diamond-shaped.

Atrial fixation member 102 may be made of any biocompatible material, such as stainless steel, nickel-titanium alloy, or polymer. Atrial fixation member 102 may be an elastic self-expanding material or a balloon expandable material. According to a currently preferred embodiment, atrial fixation member 102 is formed from a superelastic nickel-titanium alloy, such as Nitinol®, which is self-expanding.

The prosthetic valve leaflet device 100 has a vertical axis VA in the direction of blood flow from the atrium to the ventricle and a horizontal axis HA perpendicular to the vertical axis. Prosthetic leaflet device 100 has a proximal side P and a distal side D. The prosthetic leaflet device 100 has a proximal or leading end facing the atrium and a distal or trailing end facing the ventricle.

Atrial fixation member 102 surrounds or otherwise defines a lumen 102L that, when expanded, spans a portion of the left atrium. Atrial fixation member 102 may be covered in whole or in part with an optional biocompatible coating 108. The biocompatible coating 108 can facilitate sealing and/or tissue ingrowth, which can aid in long-term fixation of the device 100. The optional biocompatible coating 108 of the atrial fixation member 102 may be continuous with or without apertures or windows, or the biocompatible coating 108 may be discontinuous with discrete sections. As a result, the gaps or uncovered portions of the atrial fixation member 102 are interposed between the covered portions. The biocompatible covering 108 may be a fabric formed from a polymer or biomaterial, such as polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), silicone, urethane, pericardium, etc. Coating 108 may be attached to atrial fixation member 102 by any conventional means, including sutures, adhesives, sintering, and the like. Covering 108 may be sewn to the inner surface of atrial fixation member 102, ie, the surface of the atrial fixation member facing lumen 102L. Alternatively, the covering 108 is attached to the outer surface of the atrial fixation member 102, ie, the side facing away from the lumen 102L, which in use is the side facing the atrial wall.

Atrial fixation member 102 is configured and shaped to atraumatically provide adequate fixation of prosthetic valve leaflet device 100 within the left atrium and to permit delivery, positioning, and retrieval of the device. . In the embodiment shown in FIGS. 2A-2C, the uppermost row of struts of the atrial fixation member 102 form a plurality of inverted V-shaped structures or crown points (eg, chevrons 102V). One or more of the chevrons 102V may each have an eyelet 110 at the apex of the inverted V-shaped crown location. Eyelet 110 is a suture used to deliver, orient, and retrieve prosthetic leaflet device 100 into a delivery catheter (not shown), or to deliver, orient, and retrieve prosthetic leaflet device 100 from a delivery catheter. It is dimensioned to receive a yarn strand (not shown). Chevron 102V may extend generally vertically (parallel to vertical axis VA) or may be angled toward lumen 102L to minimize any trauma to the atrial wall. , whereas the remainder of the atrial fixation member 102 flares outward (eg, away from the lumen 102L) to have a frustoconical shape. Chevron 102V may be angled toward lumen 102L.

The prosthetic valve leaflet device 100 shown in FIGS. 2A-2E utilizes atrial fixation to hold the device in place. The unconstrained size of the atrial fixation member 102 may be somewhat larger relative to the size of the atrium during diastole so that the leaflet prosthesis device 100 remains in its desired position. The atrial anchoring member 102 is configured to be positioned above the mitral valve annulus so that it does not adversely affect the function of the other leaflets of the mitral valve. The atrial fixation member 102 may include a plurality of frictional engagement portions or cleats 112 that frictionally engage the tissue of the atrial wall without penetrating the tissue, i.e., It penetrates into the tissue in a tent-like manner. However, the cleat 112 may have a sharp tip or barb configured to penetrate into the atrial wall. Cleat 112 may be integrally formed with strut 104 or may be attached to strut 104 in a different manner. The cleat 112 may (a) be directed toward the eyelet 110 (i.e., opposite to the direction of blood flow, e.g., upwardly, proximally, toward the top of the atrium, or from the ventricle in mitral valve applications); (b) directly outwardly into the atrial wall; and/or (c) downwardly (in the direction of blood flow, downwardly, distally) away from eyelet 110. lateral, toward the ventricle, or away from the atrium in mitral valve applications), or the cleat may extend in multiple directions. The cleat 112 may be provided all the way around the circumference of the atrial fixation member 102, or the cleat 112 may be provided only on portions of the atrial fixation member 102. For example, cleats 112 may be provided on the anterior and posterior segments of atrial fixation member 102 rather than on the outer segments of atrial fixation member 102. The leaflet prosthesis device 100 may utilize atrial fixation using a cleat 112 and/or an atrial fixation member 102 that is oversized relative to the atrium to hold the leaflet prosthesis device 100 in place. It's good. The atrial anchoring member 102 is configured to be located slightly above the valve annulus (eg, 1-10 mm) so that, with the exception of the baffle 114, the prosthetic leaflet device 100 is not attached to the valve annulus. It has become.

Baffle 114 extends distally (eg, in the direction of blood flow) from the posterior portion of atrial fixation member 102 . Baffle 114 provides an artificial coaptation surface for the anterior leaflet, which displaces a natural leaflet that is damaged or otherwise does not coapt well with the anterior leaflet. See Figure 2D-1 for this. Baffle 114 may be shaped to provide these functions while facilitating or otherwise enabling mating with other cusps and promoting blood flow around the baffle. The baffle 114 has, for example, a teardrop shape and tapers from the spherical junction surface toward the posterior wall of the left atrium as it extends upward. (See, for example, FIG. 3E).

Baffle 114 may be integral with atrial fixation member 102 such that it is made from the same metal frame. Baffle 114 may alternatively be made from a separate element and connected to a portion of atrial fixation member 102, such as by struts provided on baffle 114 or atrial fixation member 102.

In some embodiments, baffle 114 may be made of biocompatible foam attached to atrial fixation member 102. Baffle 114 may alternatively have an adjustable shape to facilitate sealing with other cusps, such as baffle 114 having an inflatable bladder attached to atrial fixation member 102. Also good.

Baffle 114 can also contribute to securing the prosthetic leaflet device 100. The rear portion of the baffle 114 may include a friction element, such as a cleat 112, configured to engage the posterior leaflet and/or the annulus. The rear portion of baffle 114 may also be shaped to engage the geometry of the valve annulus, ventricular wall, and atrial wall. For example, the rear portion of baffle 114 may have a concave shape from the atrial end to the ventricular end to engage the valve annulus and thereby prevent movement toward the atria or ventricles.

Referring to FIGS. 2A-2C, baffle 114 may have a basket-like shape with a surrounding or surrounding hollow interior. The basket-shaped baffle 114 may have a forward strut 116 (FIGS. 2B and 2C) connected to an aft strut 118 (FIGS. 2A and 2C) by a bridging portion 120 (FIG. 2E-2). A biocompatible sheath 122, which may be the same material used for sheath 108, is attached to baffle 114 to provide a fluid-tight seal with adjacent leaflets of the valve. The anterior strut 116 may be connected to or integrally formed with the bridging portion 120 and the posterior strut 118, for example from a single tubular mesh. In this embodiment, baffle 114 is the only portion of prosthetic leaflet device 100 that extends across the valve annulus and into the ventricle. See FIG. 2D for this.

The baffle 114 can be of various shapes to facilitate mating with the posterior wall and adjacent leaflets, as well as to ensure proper closure of the valve, optimizing blood flow and preventing turbulence and/or clot formation. can be taken. Baffle 114 may also be configured to optimize the stability of baffle 114 throughout the cardiac cycle and for ease of deployment and retrieval. In many embodiments, the anterior strut 116 projects into the lumen 102L and has a convex shape configured to provide an atraumatic interface for the anterior leaflet AL. (See for example FIG. 2E).

The anterior struts 116 span a width (perpendicular to the vertical axis VA) that may be independent of the width spanned by the posterior struts 118. The spanning width of the anterior struts 116 is uniform along their length such that the width at the proximal end 116A is equal to the width at the distal end 116B as shown in FIG. 2C. It's good to be like that. However, in some embodiments, the spanning width of the anterior strut 116 at the proximal end 116A is slightly longer than the width at the distal end 116B forming a wing-like portion, thereby providing a seal. Fastening and joining can be facilitated. Anterior strut 116 is adapted to provide an atraumatic interface for the anterior leaflet. Therefore, the forward strut 116 preferably does not include any cleats 112. Additionally, the width of the anterior struts 116 and/or the spacing between the struts may be adjustable to ensure an atraumatic coaptation structure for the anterior leaflet. In other words, the forward struts 116 may be more widely or more closely spaced than the struts 104 and/or the struts 118.

The posterior struts 118 may be generally parallel to the vertical axis VA, or they may have a somewhat arcuate shape to match the ventricular wall. In other embodiments, the posterior struts 118 may extend at an angle toward the lumen 102L to reduce contact with the ventricular wall and papillary muscles compared to struts that are parallel to each other. The posterior struts 118 are oriented at an angle alpha (shown in FIG. 3B) ranging from 0° to 70° relative to the vertical axis VA to reduce or increase contact with the ventricular wall. It may also extend at an angle beta in the range 90° to 180°. By reducing the contact between the posterior struts 118 and the vertical wall, the prosthetic leaflet device 100 can remain in a more consistent position relative to the native annulus. This is expected to provide consistent coaptation between the prosthetic leaflet device 100 and the opposing native leaflet. Alternatively, providing a concave shape (angle beta of less than 180° between the atrial and ventricular portions of the posterior wall) allows for proper positioning of the device over the annulus and for positioning the device in the atrial or ventricular direction. It becomes easier to help prevent the movement of

Posterior strut 118 can include a cleat 112 (FIG. 2B) to help secure the prosthetic leaflet device 100. For example, the cleat 112 abuts and engages with the posterior leaflet PL. In some embodiments, the cleat 112 can also engage the posterior annulus or ventricular wall. The cleat 112 at the ventricular end of the baffle 114 may be short to engage the thin posterior leaflet tissue, whereas the cleat at the annular end of the baffle 114 engages the annular tissue. The longer the better.

The width W spanned by the posterior strut 118 is preferably configured to span the entire width of the posterior leaflet (eg, 25-55 mm) including all three scallops P1, P2, and P3. However, according to currently preferred embodiments, the spanning width of the posterior struts 118 is less than the total width of the posterior leaflet PL. Specifically, the aft strut 118 is calibrated to be somewhat wider than the width of the intermediate scallop P2 (e.g., 20-35 mm) such that the strut 118 displaces only the intermediate scallop P2. and at least partially immobilizes it or engages only part of the scallops P1, P3. Thereby, the scallops P1, P3 or at least parts of the scallops P1, P3 remain at least somewhat intact, so that these scallops can move and the baffle 114 and/or segment A1 of the posterior leaflet, A3 (for this, see the dashed lines of scallops P1 and P3 shown in FIG. 2D-2). As a result, if baffle 114 is slightly wider than intermediate scallop P2, baffle 114 will engage all of scallop P2, even if prosthesis 100 is slightly rotationally misaligned with the mitral valve. Even if it is the case, it is joined to the scallops P1 and P3.

In this embodiment, the anterior strut 116 and the posterior strut 118 have a hollow interior volume and a basket or pocket 124 (Fig. 2C). (See also Figure 2D-2 in this regard). Apart from the opening 126, the basket 124 is sealed on all sides by a covering 122. As mentioned above, the fabric covering 108 of the atrial fixation member 102 is completely optional and is also discontinuous as it is used for tissue ingrowth or protection as opposed to providing a fluid-tight seal. It's good. In contrast, the fabric covering 122 of the baffle 114 is adapted to provide a fluid-tight seal with the ventricular wall and other leaflets of the valve. The shape of the basket 124 is configured to promote blood circulation through the hollow interior of the basket 124 and to inhibit the accumulation of stagnant blood, thereby inhibiting thrombus formation. Additionally, the fabric covering 122 is preferably smooth to minimize any trauma to the anterior leaflet when the anterior leaflet abuts the covering 122.

The covering 122 may be attached to the anterior and posterior struts 116, 118 by any conventional means, including sutures, adhesives, sintering, and the like. Sheath 122 is adapted to provide an atraumatic interface for the anterior leaflet and to prevent leakage of blood in the retrograde direction during systole. Coating 122 may be formed from the same material used for coating 108 described above.

Pocket 124 may also be inverted so that mouth 126 faces downward (distally) toward the ventricle, away from eyelet 110. Furthermore, the mouth or opening 126 of the basket 124 may be sealed with a coating 122, thereby completely enclosing the interior volume of the pocket 124. This may be advantageous in ensuring non-turbulent blood flow and preventing thrombus formation.

Prosthetic valve leaflet device 100 is implanted within the atrium of the mitral valve such that baffle 114 is the only portion of the device in contact with or across the plane of the valve annulus. (See Figure 2D for this). Baffle 114 may inadvertently contact the valve annulus as it extends into the ventricle. In some embodiments, the posterior struts 118 are provided with cleats 112 to engage the annulus, but the prosthetic leaflet device 100 is not otherwise secured to the annulus. In particular, in certain applications, the lower edge of the atrial fixation member 102 may be 1-10 mm, 1-8 mm, 1-6 mm, 1-4 mm, 3-9 mm, 3-6 mm, 2 mm, 3 mm, 4 mm below the annulus. , 5mm, 6mm, 7mm, 8mm, or 9mm above the atrial wall such that the anterior leaflet is free to open and close under normal physiological conditions. It is designed to only come in contact with The atrial fixation member 102 is configured such that the anterior segment of the atrial fixation member 102 is 10 to 30 mm, 10 to 20 mm, 10 to 15 mm, 15 to 30 mm, 15 to 25 mm, 15 to 20 mm, 20 to 30 mm, 10 It may be located ~25 mm, 25-30 mm, 10 mm, 15 mm, 20 mm, 25 mm, or 30 mm above, or angled so that it is positioned against the lid of the left atrium. As a result, baffle 114 is the only portion of prosthesis 100 that extends into the left ventricle. (See Figure 2D for this).

In some embodiments, the prosthetic valve leaflet device 100 is constructed by (a) the atrial anchoring member 102 against the atrial wall and the frictional engagement of the cleat 112 with the atrial wall; and (b) the anterior leaflet PL and the valve. It is held in place by engagement of baffle 114 and optional cleat 112 of baffle 114 to the hoop. (See, eg, FIG. 2D-1 in this regard.) Atrial anchoring member 102 is thus advantageous in biasing cleat 112 into engagement with the atrial wall. For example, the unconstrained size of the atrial fixation member 102 may be slightly larger than the diastolic size of the atrium, and the atrial fixation member 102 may bias the cleat 112 to cause it to rub against the atrial wall. It may be formed of a superelastic material, such as Nitinol®, configured to exert an engaging force (away from lumen 102L). If the atrial fixation member 102 is made of a balloon-expandable material, such as stainless steel, the atrial fixation member 102 is expanded such that the cleat 112 engages the atrial wall during atrial diastole as well as during atrial contraction.

The atrial fixation member 102 may have an asymmetrical shape, with the proximal edge of the anterior portion of the atrial fixation member 102 being vertically displaced relative to the proximal edge of the posterior portion of the atrial fixation member 102. Additionally, the height of the anterior portion of the atrial fixation member 102 may be higher or shorter than the posterior portion of the atrial fixation member 102.

The stiffness of the atrial fixation member 102 may be non-uniform, with different portions of the atrial fixation member 102 being stiffer than other portions. For example, the anterior portion of the atrial fixation member 102 may be more flexible than the posterior portion of the atrial fixation member 102, or vice versa. There are many ways to accomplish this. For example, the stiffness of a portion of the atrial fixation member 102 may be increased by making the struts shorter, thicker, or wider, such that one portion of the atrial fixation member 102 is stiffer than another, or by making the struts shorter, thicker, or wider, or by Can be adjusted by shortening the spacing between the mating struts.

It may be desirable to modify or otherwise control the shape of the baffle 114 in the field to ensure anterior leaflet-baffle bonding and sealing of the anterior leaflet with the baffle. There are many ways to accomplish this.

Baffles with Inflatable Bladders Figures 2E-1 to 2F-3 illustrate techniques for adjusting the size and/or shape of the baffle 114 in situ (in the body). 2E-1 and 2E-2 show bladder 115 inserted into hollow interior 124 of baffle 114. Bladder 115 may be selectively inflated in situ with saline, blood, gel, or polymer through inflation lumen 117, which extends outside the body. Inflation of bladder 115 changes the shape of the baffle. In particular, inflation of bladder 115 adjusts the amount that baffle 114 protrudes into lumen 102L. The anterior struts 116 deform preferentially inward toward axis VA-VA while the posterior struts 118 do not deform or to a lesser extent than the anterior struts 116 deform inwardly. It may be configured to be less stiff than the rear struts 118 to allow for outward deformation. Inflating bladder 115 flexes the anterior strut into lumen 102L and reduces the distance the anterior (opposed) leaflet must travel to engage the atraumatic surface of baffle 114. It may be useful for the anterior strut 116 to be made of stainless steel or the like to allow the bladder to plastically (permanently) reshape the anterior strut 116.

2F-1 through 2F-3 depict one or more bladders 115 (e.g., identified in FIG. 2F-1 as bladders 115A through 115C are shown) facing forward of baffle 114. Figure 5 illustrates another approach for adjusting the dimensions of an artificial joint surface by providing on a section. A first bladder 115A may be provided on the central portion of the anterior strut 116, and this bladder may be dimensioned to coincide with the central lobe A1 of the anterior leaflet. Alternatively, the first bladder 115A may be dimensioned to span the entire width of the baffle 114 such that it coincides with all three lobes A1, A2, A3. In this case, the first bladder 115A serves as an atraumatic interface. Inflating the bladder changes the amount that the first bladder 115A extends into the lumen 102L, thereby reducing the spacing between the baffle and the anterior leaflet.

FIG. 2F-3 shows an instrument 250 configured such that bladders 115A, 115B, 115C on anterior struts 116 match scallops A1, A2, A3 of the anterior leaflet. Each of bladders 115A-115C is independently inflatable to further control the shape of baffle 114. As a result, the instrument 250 is shapeable in the field to allow rotational displacement of the instrument 250 relative to the anterior leaflet scallops A1, A2, A3 or relative to unique features of a particular anterior leaflet.

Actuation of the baffle shaft 119 with an adjustment mechanism adjusts the location of the proximal (atrial) connection between the baffle and the atrial fixation member, thereby adjusting the amount that the baffle 114 extends into the lumen 102L. be done. Another approach to adjusting the size and shape of the baffle is to use one or more adjustment mechanisms 117, such as a worm drive, operatively coupled to the baffle 114 and actuated by a shaft 119 from outside the body. 117A (FIG. 2H) or ratchet 117B (FIGS. 2G-1 to 2G-3). 2G-1 to 2G-3 show how the shape of baffle 114 with ratchet 117B is adjusted by pushing on shaft 119. For example, when shaft 119 is inserted into ratchet 117B, shaft 119 causes baffle 114 to curve further. As a result, actuation of shaft 119 adjusts the location of the proximal (atrial) connection between the baffle and the atrial fixation member, thereby adjusting the amount that baffle 114 extends into lumen 102L. A suture or cable (not shown) is operatively coupled to the ratchet release device to facilitate unlocking of the ratchet. The sides of baffle 114 may be covered with an expandable material 122, such as PTFE or urethane, to allow expansion or contraction of baffle 114.

FIG. 2H shows one embodiment of a prosthetic leaflet device with an adjustment mechanism consisting of a worm drive 117A to change the shape of the baffle 114. In operation, a shaft 119 with an engagement element at its distal end is engaged with the worm drive 117A. The shaft 119 is rotated, thereby shortening the worm drive 117A. The shortening of the worm drive 117A causes the baffle 114 to bend so that the baffle 114 extends further into the lumen of the prosthetic valve leaflet device. As a result, worm drive 117A can adjust baffle 114 to provide the desired amount of coaptation with the natural leaflets.

Prosthetic Leaflet Device with Skirt or Hem FIG. 2I shows a posterior leaflet device 200 that is a slight modification of the posterior leaflet device 100 shown above. Identical reference numbers indicate identical or nearly identical features. Prosthesis 200 has an annular hem 202 depending or extending from the distal end of the atrial fixation member in the direction of blood flow (eg, distally or toward the annulus). The annular hem 202 has a sheath 204 and a structural reinforcement 206 that biases the sheath 204 away from the lumen 102L, ie, toward the atrial wall. Structural reinforcement 206 may be coupled to prosthesis 200 by sheathing 204 or otherwise not attached to prosthesis 200. Sheath 204 may be integrally molded with or integrally connected to sheaths 108, 122, or sheath 204 may be attached to atrial fixation member 102. Coating 204 is configured to promote tissue ingrowth and can be formed of a material similar to coating 108 or a different material. Structural reinforcement 206 is adapted to provide only annular (radial) support for cladding 204, and the structural reinforcement 206 is adapted to provide only annular (radial) support for cladding 204, which supports vertical movement of the cladding, ie parallel to vertical axis VA. It is specially constructed so as not to restrict movement. More specifically, structural reinforcement 206 urges sheathing 204 away from lumen 102L (and into the atrial wall). In use, the prosthetic leaflet device 200 is implanted in the left atrium so that the heme 102 is slightly (0-10 mm) above the mitral annulus.

Chevronless Prosthetic Leaflet Device FIGS. 3A-3E illustrate a leaflet prosthetic device 250 that is a variation of the posterior leaflet device 100. Identical reference numbers indicate identical or nearly identical features. Prosthetic leaflet device 250 does not include chevrons 102V (FIGS. 2A and 2B) for transporting and positioning prosthetic device 100. In place of the chevrons 102V and eyelets 110, the prosthetic leaflet device 250 includes a first set of suture loops 252 that at least partially span the circumference of the baffle 114 and a first set that spans at least partially the circumference of the atrial fixation member 102. There may be two sets of suture loops 254. The first and second sets of suture loops 252, 254 include two or more suture loops. In the illustrated embodiment, a second set of suture loops 254 are provided near the distal end of atrial fixation member 102, but loops 254 can be placed anywhere on atrial fixation member 102 as desired. Can be positioned at a location. A third set of loops may be provided on the atrial fixation member 102 if desired, and this third set of loops may be tightened separately and independently of the suture loops 252, 254. Suture loops 252, 254 are configured to receive filaments (sutures) 252S, 254S, etc., which can be secured to atrial fixation member 102 and/or baffle 114 by tightening the sutures. Can be used to selectively crush. Baffle 114 and atrial fixation member 102 can be collapsed independently of each other. Collapsing the atrial fixation member 102 and baffle 114 facilitates repositioning and/or re-sheathing and removal of the prosthetic leaflet device 250.

One or more additional suture loops 256 may be provided on the baffle 114 and are configured to receive filaments (sutures) 256S. Suture loop 256 is optional and such a suture loop can be used to compress baffle 114 for repositioning or removal. The suture loops 256 can also be used to evert the leaflet prosthesis device 250 by pulling the suture 256S as an alternative method of disengaging the leaflet device 250 from the annulus for repositioning and/or resheathing of the prosthesis 250. available for use. In the illustrated embodiment, third suture loop 256 is provided on the anterior side of baffle 114, ie, on the side facing lumen 102L.

As best seen in FIG. 3B, the rear struts 118 of the baffle 114 may extend at an angle alpha relative to the vertical axis. In other words, baffle 114 may be angled inwardly away from the ventricle and toward lumen 102L in the direction of blood flow. This configuration spaces the downstream end of baffle 114 radially inwardly of the ventricular wall, or at least The force exerted on baffle 114 by the ventricular wall is reduced. This is expected to reduce motion of the prosthesis 250.

Alternatively, the rear side of baffle 114 may include a small notch or other extending outwardly at a height corresponding to the position of the natural annulus on baffle 114 to provide additional clearance for the annulus. It is preferable to have a recess (not shown). Alternatively, the posterior side of the baffle 114 may extend outward toward the ventricular wall to increase the radially outward force exerted on the native annulus and aid in anchoring it to the posterior, somewhat annular space. (away from lumen 102L).

In some embodiments, baffle 114 is formed of biocompatible foam. The foam may be compressible to allow delivery through small diameter catheters and may be self-expanding to resume its desired shape after delivery. A portion or all of the foam baffle 114 may be further covered with a biocompatible material, such as expanded polytetrafluoroethylene, to enhance tissue ingrowth or atraumatic nature of the interface. Baffle 114 may have a teardrop shape, for example. (See, for example, FIG. 3E). For example, struts may be provided on the rear portion of the foam baffle 114, and these struts are connected to the rear portion of the atrial fixation member. The rear portion of the baffle 114 may include a friction element, such as a cleat 112, configured to engage the posterior leaflet and optionally the annulus.

Prosthetic Valve Leaflet Devices with Partial Anterior Ventricular Fixation Members FIGS. 4A and 4B have an atrial fixation member 302 configured to span some or all of the circumference (e.g., scallops A1, A2, A3) of the anterior leaflet. A prosthetic valve leaflet device 300 is shown. Atrial fixation member 302 may have struts 304 in a diamond pattern or other suitable pattern. Each cell of atrial fixation member 302 defines an opening or through-hole 306. It is preferable that the unrestricted shape of the Shinpo Utsuki 302 has a circular or oval shape as a whole. Atrial fixation member 302 includes any number of through holes 106 or any number of holes such that atrial fixation member 302 contacts the left atrial wall with at least a threshold amount of radial force to fix the position of prosthetic valve leaflet device 300. It can have any shape or size. The radial force can be adjusted by varying the shape and dimensions of the struts (eg, thickness, width, and spacing between struts) and the shape and dimensions of the through holes 306.

Atrial fixation member 302 may be made of any biocompatible material, such as stainless steel, nickel-titanium alloy, or polymer. Atrial fixation member 302 may be an elastic self-expanding material or a balloon expandable material. According to a presently preferred embodiment, atrial fixation member 302 is formed from a superelastic nickel-titanium alloy that is self-expanding, such as Nitinol®.

Prosthetic leaflet device 300 further includes a baffle 314 attached to or integral with atrial anchoring member 302. The atrial fixing member 302 and the baffle 314 cooperate to form a lumen 302L through which blood flows. Baffle 314 is configured to protrude into lumen 302L to provide an atraumatic interface for the anterior leaflet. In use, prosthesis 300 is implanted with atrial fixation member 302 located within the atrium and baffle 314 extending from the atrium across the annulus and into the ventricle. All or part of the anterior leaflet is pushed out of the way by baffle 314. Some embodiments of the prosthesis 300 are dimensioned to match the central lobe P2 of the posterior leaflet without contacting at least a portion of the lobes P1, P3, so that the lobes P1, P3 remain stationary. and can be joined to baffle 314. This allows baffle 314 to be smaller than baffle 114 described above, which is expected to reduce the forces exerted on baffle 314 to facilitate long-term fixation of prosthesis 300.

Atrial anchoring member 302 and/or baffle 314 are optionally adapted to frictionally engage (non-invasively) the valve annulus, atrial wall, and/or posterior leaflet without penetrating (penetrating) tissue. It is preferable to include a friction element such as a cleat 312. If desired, cleat 312 can have a pointed end configured to penetrate into tissue. In some embodiments, cleats are provided on the anterior portion of the atrial fixation member 302 and the posterior portion of the baffle 314. In certain embodiments, cleat 312 is not provided on the outer side of either atrial fixation member 302 or baffle 314. Cleat 312 can engage the anterior atrial wall, the posterior leaflet, and/or the posterior annulus. Prosthetic valve leaflet device 300 may include additional anchoring elements, such as hooks, barbs, screws, etc.

In some embodiments, baffle 314 is formed of biocompatible foam. The rear portion of the baffle 314 may include a friction element, such as a cleat 312, configured to engage the posterior leaflet and optionally the annulus.

In other embodiments, baffle 314 can be an open or closed basket-type baffle, such as the baffle shown in FIG. 2B. Baffle 314 may be substantially similar to baffle 114 described above with reference to FIGS. 2B and 2C, for example, such that forward struts 316 and aft struts 318 (FIG. 4B) form a portion of baffle 314. However, these struts may be coated with a biocompatible coating 322, which may be the same material used for coating 108 described above. Baffle 314 is configured to provide an atraumatic interface for the anterior leaflet in mitral valve applications. As mentioned above, the spacing between the struts 316 and the width of the struts 316 can be varied to ensure providing an atraumatic interface for the anterior leaflet.

Triangular Anchors and/or Posterior Hooks FIGS. 5A and 5B illustrate another prosthetic leaflet device 450 that is a variation of prosthetic device 300. The prosthesis 450 includes a fixation ring 402 (e.g., a partially circular ring, a partially oblong ring) configured to span part or all of the posterior leaflet (scallops P1, P2, P3) to the posterior commissure. ring, etc.). Posterior leaflet device 450 replaces atrial fixation member 302 of prosthesis 300 with one or more triangular extensions 416, 416A. The triangular extensions 416, 416A extend to the fiber triangle (FIG. 1). To avoid hitting the anterior leaflet, the triangular extension may be offset vertically (proximally - toward the atrium and away from the annulus) and/or curved around the periphery of the annulus. It's good. Prosthesis 450 may optionally include a cleat 412 on baffle and/or ring 402. Although FIG. 5A shows a prosthesis 450 with both a triangular extension and a posterior hook, the illustrated embodiment is not a limitation of the present invention; therefore, each of these features In addition to or in place of the member and posterior cleat, they can be separately incorporated into prosthesis 450. The triangular extensions 416, 416A are adapted to engage the fiber triangles. Triangular extension 416 has an anchor at the distal end of the extension that is configured to penetrate into the fibrous trine, whereas triangular extension 416A has an anchor configured to penetrate into the fibrous trigone. It has an atraumatic (curved or blunt) end adapted for invasive engagement. For illustrative purposes, the prosthetic leaflet device shown in FIG. It has a set of common triangular extensions 416A.

Triangular extensions 416, 416A extend from ring 402 to the fiber triangle (parallel to horizontal axis HA). Triangular extensions 416, 416A may be straight or curved. To minimize disruption of the normal motion of the anterior leaflet, it may be desirable for the triangular extensions 416, 416A to have an arcuate shape around the periphery of the anterior annulus. Additionally or alternatively, a triangular extension may extend somewhat perpendicularly (proximally) from ring 402 to avoid the anterior leaflet.

Prosthetic leaflet device 450 may optionally include one or more posterior hooks 420 attached to the posterior portion of ring 402. Although not separately shown, a posterior hook 420 may be provided in place of or in addition to the posterior cleat 412 to engage the posterior leaflet and posterior annulus. The posterior hook 420 is configured to atraumatically engage a generally straight portion 420V extending distally in a generally vertical direction and the ventricular side of the annulus, posterior ventricular wall, and/or edge of the posterior leaflet. It has a rearwardly curved portion 420C.

Prosthetic valve leaflet device 450 has a baffle 414 attached to distal segment ring 402 that projects into lumen 402L and provides an atraumatic interface for the anterior leaflet. In mitral valve applications, prosthesis 450 is implanted with triangular extensions 416, 416A located at the level of the annulus, so that baffle 414 extends into the ventricle. Baffle 414 displaces all or part of the posterior leaflet out of the way. According to some embodiments, the prosthesis 450 is sized to coincide with the central lobe P2 of the posterior leaflet so that the lobes P1, P3 are movable and can interface with the baffle 414. See FIG. 6B for this.

In some embodiments, baffle 414 is formed of biocompatible foam. Baffle 414 may have a teardrop shape, for example. In other embodiments, the baffle 414 has the shape of a basket surrounding the hollow interior volume as shown and described with reference to FIG. 2B. Thus, the basket-shaped baffle 414 may have a plurality of struts covered by a biocompatible coating 408, which may be the same material used for the coating 108 described above. good. Baffle 414 is configured to prevent retrograde blood flow and provide an atraumatic interface for the anterior leaflet.

Prosthetic Valve Leaflet Device with Posterior Atrial Fixation Member FIGS. 6A and 6B show a prosthetic valve leaflet device 600 having a fixation ring member 602 formed of a mesh, e.g., braid or stent-like structure; 602 has wires or struts 604 that constitute a plurality of cells, each cell having a through hole or opening 606. For clarity, the prosthetic leaflet device 600 is shown inverted for mitral valve applications, with the downstream end positioned above the upstream end. The size, shape, and number of openings 606 are selected to optimize radial forces to ensure fixation. An optional bridging element 602B (shown in phantom) may connect the ends of the fixed ring member 602 to each other such that the bridging element 602B and the fixed ring member 602 cooperate to connect the ends of the fixed ring member 602 to the lumen 602L. The lumen 602L fluidly couples the atria and ventricles during operation. Ring segment 602 and bridging element 602B may be made of a biocompatible material, such as a superelastic self-expanding material, such as a nickel-titanium alloy, or a balloon-expandable material, such as stainless steel. Can be mentioned. For example, ring segment 602 and bridging element 602B are formed from a nickel-titanium alloy.

Prosthesis 600 has a vertical axis VA, which is the direction of blood flow from the atrium to the ventricle, and a horizontal axis perpendicular to the vertical axis. Prosthetic valve leaflet device 600 has an anterior side and a posterior side.

Ring element 602 has a plurality of baffle supports (struts) 618 (FIG. 6B) attached to or integrally formed with ring 602. Prosthesis 600 further includes baffles 614 attached to struts 618.

In some embodiments, baffle 614 is formed of biocompatible foam. Baffle 614 may have a teardrop shape, for example. The rear portion of baffle 614 and/or struts 618 can have a plurality of frictional engagement portions or cleats 612 configured to engage the posterior leaflet and optionally the annulus.

In other embodiments, baffle 614 may have a basket shape (such as baffle 114 shown in FIG. 3A) such that biocompatible coating 608 forms a convex atraumatic surface. Attached to struts 618, the anterior leaflet can be joined to this convex atraumatic surface. Baffle 614 projects into lumen 602L such that a portion of baffle 614 approaches the closed position of the posterior leaflet. The smoothness of the baffle, the width of the struts 618, and the spacing between the struts 618 all contribute to providing an atraumatic interface.

The biocompatible covering 608 can be a fabric formed from a polymer or biomaterial, such as polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), silicone, urethane, pericardium, etc. Coating 608 may be attached to ring segment 602 by any conventional means, including sutures, adhesives, sintering, and the like. In some embodiments, the covering 608 can be sewn to the struts 618.

The uppermost row of struts 604 of the fixation ring 602 located at the most upstream end of the prosthesis 600 form a plurality of inverted V-shaped structures or crown points or chevrons 604V. Some (but not necessarily all) of the chevrons 604V have an eyelet 610 at the apex of the V. Eyelet 610 is used to deliver, direct, and retrieve prosthetic valve leaflet device 600 into, and from a delivery catheter (not shown). The suture strand (not shown) is sized to receive a suture strand (not shown). Chevrons 604V may extend generally vertically (parallel to vertical axis VA), or they may be angled toward lumen 602L.

The fixation ring 602 and bridging portion 602B can include a plurality of frictional engagement elements or cleats 612 adapted to frictionally engage the wall of the atrium. In some embodiments, the cleat 612 can have a pointed end configured to penetrate into the tissue of the atrial wall. The fixation ring 602 is configured to straddle the posterior mitral annulus with a portion of the ring located within the atrium and a portion within the ventricle. The bridging portion 602B is configured to extend from the anterior commissure to the posterior commissure to circumscribe the anterior annulus or possibly avoid interference with the posterior leaflet; such bridging portion does not extend into the ventricle. Cleats 612 may be integrally formed with or integrally attached to struts 604, and the cleats 612 may be integrally formed with or integrally attached to struts 604, and these cleats may be disposed upstream toward eyelet 610 (e.g., proximally, for mitral valve applications). cleats may extend downstream away from the eyelet 610 (e.g., distally, toward the ventricle), or the cleats may be oriented in both directions. . Cleat 612 is integrally formed with the strut and extends proximally toward eyelet 610.

Prosthetic Leaflet Device with Posterior Hooks FIGS. 7A-7C show a prosthetic valve leaflet device 700 having a fixation ring segment 702 formed of mesh or stent-like material, where the fixation ring segment 702 includes a plurality of cells. 704, each cell having a through hole or opening 706. The size, shape, and number of openings 706 may be configured to allow sufficient fixation of prosthesis 700 without exerting too much force on tissue. The prosthesis 700 can further include a bridging element 702B, which and the ring segment 702 together define a lumen 702L that fluidly couples the atrium and ventricle during actuation. The ends of the ring segments 702 are connected to each other. Ring segment 702 and bridging element 702B may be formed from any biocompatible material, including superelastic self-expanding materials such as nickel-titanium alloys or balloon expandable materials such as stainless steel. It will be done. For example, ring segment 702 and bridging element 702B are formed of a nickel-titanium alloy in certain embodiments. Ring segment 702 has a plurality of baffle supports (struts) 713 attached to or integrally formed with ring snow surface 702.

Prosthesis 700 further includes baffles 714 attached to struts 713. In some embodiments, baffle 714 is formed of biocompatible foam. Baffle 714 may have a teardrop shape, for example. The rear portion of baffle 714 can have a plurality of frictional engagement portions or cleats 712 configured to engage the posterior leaflet and optionally the annulus. In other embodiments, the baffle can have a basket shape (e.g., baffle 114 in FIG. 3A) with a biocompatible coating 708 that is attached to the support 713 to form the baffle 714. The baffle 714 provides an atraumatic surface against which the anterior leaflet can abut. The biocompatible covering 708 can be a fabric formed from a polymer or biomaterial, such as polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), silicone, urethane, pericardium, etc. Coating 708 may be attached to ring 702 by any conventional means, including sutures, adhesives, sintering, and the like. Thus, in use, baffle 714 replaces the posterior leaflet.

Ring segment 702 and bridging portion 702B may include a plurality of frictionally engaging portions or cleats 712 adapted to frictionally engage the wall of the atrium. For example, the cleat 712 may "tent" into the tissue of the atrial wall without penetrating the tissue. Ring segment 702 is configured to straddle the posterior mitral annulus with a portion of the ring located within the atrium and a portion within the ventricle. Bridging portion 702B is configured to surround the anterior annulus and does not extend into the ventricle. The cleats 712 may be integrally formed with or integrally attached to the struts 704, and the cleats 712 may be integrally formed with or integrally attached to the struts 704, and the cleats may be disposed upstream (e.g., proximally, away from the ventricle) and/or downstream. The cleats may extend laterally (eg, distally, toward the ventricle), or the cleats may be oriented in both directions. In the illustrated embodiment, cleat 712 is integrally formed with the strut and extends proximally (upward).

Prosthetic leaflet device 700 can optionally include a posterior hook 720 attached to a posterior portion of ring segment 702. Posterior hook 720 is configured to atraumatically engage the ventricular side of the valve annulus, the posterior ventricular wall, and/or the free edge of the posterior leaflet. (See Figure 7C for this). This is expected to further secure the prosthetic leaflet device 700 in place while also preserving the native posterior leaflet.

Semicircular Prosthetic Leaflet Device FIGS. 8A and 8B show a prosthetic leaflet device 800 having a pair of stabilizing arms 802 and a baffle 804 attached to the stabilizing arms 802. The stabilizing arms 802 extend in an arc, such as a semicircle or semi-ellipse, such that they extend along the posterior atrial wall from the anterolateral commissure to the posterolateral commissure. The stabilizing arms 802 are configured to frictionally engage the atrial wall and are made of a balloon-expandable material having an unconstrained size, such as stainless steel or a self-expanding material, such as a nickel-titanium alloy ( For example, it can be formed of Nitinol®, whose unconstrained size ensures engagement with the atrial wall during diastole as well as systole. Stabilizing arm 802 preferably has a plurality of cleats 806 adapted to engage tissue and assist in securing prosthesis 800. Stabilizing arm 802 may optionally be covered with a biocompatible fabric covering 810 to promote tissue ingrowth.

Baffle 804 is adapted to displace the posterior leaflet and provide an atraumatic interface for the anterior leaflet, thereby preventing or at least inhibiting retrograde blood flow. In some embodiments, baffle 804 is formed of biocompatible foam. Baffle 804 may have a teardrop shape, for example. The rear portion of the baffle 804 can have a plurality of frictional engagement portions or cleats 806 configured to engage the posterior leaflet and optionally the annulus. In other embodiments, baffle 804 may have the shape of a basket surrounding a hollow interior, such as that described with reference to FIG. 2B (such as baffle 114 of FIG. 3A). A baffle 804 extends in a downstream direction (e.g., distally) from the posterior portion of stabilizing arm 802, and the baffle includes a biocompatible coating with pores to facilitate tissue ingrowth. It has a plurality of struts 808 forming a somewhat convex structure covered by 810. The posterior side of baffle 804 is configured to frictionally engage one or more lobes of the posterior leaflet. The cleat 806 in the rear portion of the baffle is not obstructed by the coating 810.

FIG. 8B shows the prosthetic leaflet device 800 with an optional strut 812 spanning another free end of the stabilizing arm 802. Struts 812 can help ensure that the stabilizing arm remains engaged with the atrial wall. Stabilizing arm 802 is configured to extend between the anterior leaflet commissure and the posterior leaflet commissure.

In use, the prosthetic valve leaflet device 800 is implanted with the baffle 804 spanning the annulus and a portion of the baffle 804 extending into the ventricle and engaging the posterior leaflet. Stabilizing arm 802 may remain located within the atrium and surrounds the periphery of the valve annulus.

Deployment of Prosthetic Leaflet Devices Each of the prosthetic leaflet devices disclosed herein may be delivered in a transseptal, transatrial, or transapical manner. The implant may be delivered through a sheath having an inner diameter of, for example, 3-9 mm, 4-8 mm, 5-7 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, or 9 mm, with the distal end of the sheath positioned approximately at P2. be done. By controlling sheathing, the implant expands radially in place to abut the annulus posteriorly.

Some of the embodiments include control wires or sutures to collapse the prosthesis and allow complete retrieval of the implant for repositioning and/or resheathing within the catheter prior to final release. Take advantage of. A circumferential tightening element may also be housed within the baffle support element to facilitate controlled radial expansion during deployment and aid in radial contraction prior to complete retrieval of the implant. In other embodiments, the control wire and/or control arm bends the anterior portion of the atrial fixation member inwardly toward the posterior P2 portion of the atrial fixation member upon retrieval to reduce the overall diameter of the atrial fixation member and to It is better to ensure the separation of frictional elements from the

Some embodiments of implants according to the present technology are delivered transseptally. Prior to placement within the annulus, the prosthetic leaflet device is partially advanced out of the delivery catheter and into the atrium, where it is rotationally aligned relative to the native valve. It is a good idea to prepare for deployment. The prosthetic valve leaflet device is advanced into the valve annulus and allowed to expand and reassume its unconstrained configuration, thereby causing the valve annulus and slightly annular space to engage the frictional element posteriorly, and then A radial force engages the anterior surface of the left atrium. In one embodiment, the rear feature of the structural ring has an active (e.g., movable) hinge that folds radially inward during delivery and/or retrieval.

In some embodiments, the baffle is the first part of the prosthetic leaflet device to be deployed. This allows the baffle to be positioned in a desired location relative to the native valve, particularly the posterior leaflet and annulus in mitral valve applications. The posterior ventricular hook or cleat is then engaged to the posterior leaflet and annulus. If the prosthetic leaflet device includes a triangular extension, the triangular extension is the next portion of the prosthetic leaflet device to be deployed from the catheter. The structural ring and finally the atrial fixation member (if provided) are the last two parts of the prosthetic leaflet device to be deployed into the left atrium.

The present technical idea can be applied to other valves in addition to the mitral valve. For example, some patients suffer from aortic regurgitation due to degeneration of one of the cusps or dilatation of the aortic root. One embodiment of a device for aortic valve repair has a blocker that displaces the non-coronary leaflets of the aortic valve. The ventricular surface of the blocker is shaped approximately like the ventricular surface of the non-coronary leaflets in the closed position. This ventricular surface may be somewhat wider than the natural leaflet, so that it coheres with the other leaflet of the aortic valve. The peripheral surface of the blocker may be shaped to generally conform to the shape of the non-coronary sinus. The surface facing the aortic lumen may taper 1 to 4 cm downstream of the aortic valve (cephalad) from the coaptation surface to the aortic wall. The blocker may be coupled to a stent that is deployed within the aortic root or ascending aorta and holds the blocker in place. As in the embodiment described above, the blocker may be made of foam or an expandable metal or polymeric framework, such that the foam or expandable metal or polymeric framework provides atraumatic support for the other leaflets of the valve. It may be coated with expanded PTFE, pericardium, or other biocompatible tissue to form the sexual interface. The remaining two cusps of the aortic valve should provide a spacious lumen area if they are not narrowed, and therefore the repaired valve should provide ample space when blood is flowing through it. It does not exhibit excessive pressure gradients.

Representative Examples Some non-limiting representative examples of embodiments of the present technology are described in the enumerated embodiments section below. Representative features are described in the following embodiment sections, which may stand alone or may be combined with one or more of the disclosures in the text and/or drawings. The above features may be combined in any combination. The terms "comprises" and "comprising" and their conjugations, when used in the original specification and claims, mean that the specified feature, step, or integer is included. These terms should not be construed as excluding the presence of other features, other steps, or other components. The embodiments described above or the claims below or the accompanying drawings are disclosed in specific form or means for performing the disclosed functions or achieving the disclosed results. The features represented by or process can be used separately or in any combination of such features, as appropriate, to realize the invention in its various forms.
[Embodiment section 1]
A heart valve repair device,
an atrial fixation member with an expandable mesh having an oval or circular shape in a deployed configuration, the atrial fixation member having a central lumen;
a baffle extending from a portion of the atrial fixation member, the baffle having an anterior portion with a smooth atraumatic surface that interfaces with at least a portion of one or more native leaflets of a native heart valve; and a rear portion configured to at least partially engage and displace another native leaflet of the native heart valve, the baffle closing the displaced native leaflet. a repair device extending radially inwardly from the atrial fixation member into the central lumen to approximate position.
[Embodiment section 2]
The baffle includes a strut defining a basket having a hollow interior volume, the baffle engaging and constraining at least a first portion of the functionally defective congenital leaflet. wherein the baffle further includes a restraining portion configured to leave a second portion of the functionally defective congenital leaflet movable, wherein the baffle provides closure for the functionally defective leaflet. The repair instrument of embodiment 1, extending radially inwardly into the central lumen to approach the position.
[Embodiment section 3]
The repair instrument according to embodiment 1 or 2, further comprising a plurality of friction elements provided on a plurality of portions of the atrial fixation member or the baffle.
[Embodiment section 4]
4. A repair device according to any one of embodiments 1 to 3, wherein the inner and outer sides of the atrial fixation member do not include any frictional elements.
[Embodiment section 5]
5. A repair instrument according to any one of embodiments 1 to 4, wherein the baffle has a basket surrounding a hollow interior.
[Embodiment section 6]
In any of embodiments 1 to 5, the baffle has a plurality of front struts and a plurality of rear struts, and a gap is provided between adjacent struts of the front struts and the rear struts. The repair instrument described in item 1.
[Embodiment section 7]
a fabric covering at least partially surrounding the baffle;
7. A repair device according to any one of embodiments 1 to 6, wherein the basket has a mouth that is not covered by the fabric.
[Embodiment section 8]
a fabric covering at least partially surrounding the baffle;
7. A repair device according to any one of embodiments 1 to 6, wherein the basket has a mouth covered by the fabric.
[Embodiment section 9]
9. The repair device of embodiment 1, 3, 4, 7, or 8, wherein the baffle is comprised of biocompatible foam.
[Embodiment section 10]
A repair instrument according to any one of embodiments 1 to 9, wherein the front portion of the baffle has a convex shape.
[Embodiment section 11]
The rear portion of the baffle is dimensioned to engage the central scallop of a natural mitral leaflet having three scallops while leaving the remaining two scallops mobile. The repair instrument according to any one of aspects 1 to 10.
[Embodiment section 12]
further comprising a first set of suture loops disposed circumferentially around the atrial fixation member, each suture loop of the first set of suture loops defining a lumen. have,
a first suture disposed within the lumen of the suture loop and interconnecting adjacent suture loops;
12. The repair device of any one of embodiments 1-11, wherein the diameter of the atrial fixation member is adjusted by tightening the first suture.
[Embodiment section 13]
further comprising a second set of suture loops disposed circumferentially around the baffle, each suture loop of the second set of suture loops having a lumen. death,
a second suture disposed within the lumen of the suture loop and interconnecting adjacent suture loops;
13. The repair device of embodiment 12, wherein the diameter of the baffle is adjusted by tightening the second suture.
[Embodiment section 14]
a third suture loop provided in the baffle;
a third suture disposed within the lumen of the third suture loop;
14. The repair instrument of embodiment 13, wherein pulling the third suture displaces the baffle.
[Embodiment section 15]
Embodiments 1-14 further comprising at least one fabric segment of fabric attached to and at least partially spanning the atrial fixation member, wherein the fabric covering facilitates tissue ingrowth. A repair instrument as described in any one of the above.
[Embodiment section 16]
16. The repair device of any one of embodiments 1-15, further comprising at least one fabric segment of fabric depending from the distal end of the atrial fixation member.
[Embodiment section 17]
17. The repair instrument of embodiment 15 or 16, further comprising a biasing member attached to the at least one fabric segment and biasing the fabric segment away from the central lumen.
[Embodiment section 18]
18. A repair device according to any one of embodiments 1 to 17, wherein the atrial fixation member comprises at least two rows of cells.
[Embodiment section 19]
The atrial fixation member further includes a row of chevrons;
at least two of the chevrons have through holes;
The atrial fixation member has a suture threaded through the through hole,
19. The repair device of any one of embodiments 1-18, wherein the diameter of the atrial fixation member is adjusted by tightening the suture.
[Embodiment section 20]
20. A repair device according to any one of embodiments 1 to 19, wherein the atrial fixation member has a frustoconical shape.
[Embodiment section 21]
21. The repair device of any one of embodiments 1-20, wherein the atrial fixation member is configured to engage only the atrial wall of the native heart valve.
[Embodiment section 22]
22. The repair device according to any one of embodiments 1 to 21, wherein the size of the atrial fixation member, which is not restrained by external forces, is larger than the size of the natural atrium during diastole.
[Embodiment section 23]
23. The repair device of any one of embodiments 1-22, wherein the repair device is secured to the native heart valve only at the atrial fixation member and the baffle.
[Embodiment section 24]
The atrial fixation member has an anterior side and a posterior side, and a proximal end of the anterior side of the atrial fixation member extends perpendicularly from a proximal end of the posterior side of the atrial fixation member. 24. A repair instrument according to any one of embodiments 1-23, which is offset.
[Embodiment section 25]
The atrial fixation member has an asymmetric shape, and the length of the anterior side of the atrial fixation member is such that the anterior side of the atrial fixation member is vertically higher than the posterior side of the atrial fixation member. 25. A repair instrument according to any one of embodiments 1 to 24, which is longer than the length of the posterior side of the fixation member.
[Embodiment Section 26]
26. The repair device of any one of embodiments 1-25, wherein the posterior side of the atrial fixation member is stiffer than the anterior side of the atrial fixation member.
[Embodiment section 27]
The atrial fixation member has a plurality of interconnecting struts forming a plurality of cells, and the struts on the posterior side of the atrial fixation member are greater than the struts on the anterior side of the atrial fixation member. 27. The repair instrument of embodiment 26, wherein the repair device is at least one of thicker, wider and/or with narrower gaps between adjacent struts.
[Embodiment Section 28]
A method of repairing a regurgitant heart valve in a heart having an atrium with an atrial wall, a ventricle with a ventricular wall, a heart valve with at least two cusps having an open position and a closed position, the method comprising: a valve is disposed at the interface between the atrium and the ventricle, the heart has an annulus surrounding the heart valve, and the method includes:
providing a prosthetic valve leaflet device, the prosthetic valve leaflet device comprising:
an atrial fixation member made of a mesh material, the atrial fixation member including a central lumen configured to fluidly couple the atrium and the ventricle; the atrial fixation member includes an anterior portion, a posterior portion, a proximal portion; having a proximal end, a distal end, an inner part, and an outer part;
a baffle attached to the atrial fixation member, the anterior portion of the baffle having a smooth atraumatic surface acting as an artificial interface for one of the at least two cusps; a rearward portion of the at least two cusps is configured to engage and displace at least a portion of another one of the at least two cusps, and the baffle projects into the central lumen to close the displaced cusps. approach the position,
implanting the prosthetic valve leaflet device in the atrium such that the atrial fixation member is spaced apart from the valve annulus;
A method comprising positioning the baffle against one of the at least two cusps.
[Embodiment section 29]
The atrial fixation member of the prosthetic valve leaflet device has at least two suture loops with eyelets, a suture strand threaded through the eyelet, and when the suture strand is tightened, the atrial fixation member collapses. ,
The step of implanting the artificial valve leaflet device is as follows:
tightening the suture strand to collapse the atrial fixation member;
positioning the prosthetic valve leaflet device with the atrial fixation member collapsed within the atrium;
29. The method of embodiment 28, comprising loosening the prosthetic valve leaflet device to allow the atrial fixation member to expand into contact with the atrial wall.
[Embodiment section 30]
30. The method of embodiment 28 or 29, wherein the prosthetic valve leaflet device is secured to the heart valve only by the atrial anchoring member and the baffle.
[Embodiment Section 31]
A heart valve repair device,
an atrial fixation member having a central lumen;
a baffle attached to the atrial fixation member, the baffle having an anterior portion with a smooth atraumatic surface constituting an artificial coaptation surface for coaptation with at least one native leaflet of a native heart valve. and a rearward portion for engaging and displacing at least a portion of the functionally defective leaflet, the baffle moving the central lumen toward a closed position of the functionally defective leaflet. a heart valve repair device extending radially inwardly therein;
[Embodiment Section 32]
32. The repair device of embodiment 31, further comprising a fabric covering at least partially surrounding the baffle.
[Embodiment section 33]
33. The repair device of embodiment 31 or 32, wherein the baffle is comprised of biocompatible foam.
[Embodiment section 34]
Embodiments further comprising a plurality of friction elements disposed on a posterior portion of the atrial fixation device and the baffle, the baffle remaining in an at least substantially fixed orientation relative to the atrial fixation member. The repair instrument according to any one of Items 31 to 33.
[Embodiment Section 35]
32. The repair instrument of embodiment 31, wherein the baffle has a basket surrounding a hollow interior.
[Embodiment Section 36]
The repair device according to embodiment 35, wherein the baffle has a plurality of front struts and a plurality of rear struts, and a gap is provided between adjacent struts of the front strut and the rear strut. .
[Embodiment section 37]
37. The repair device of embodiment 35 or 36, wherein the basket has a mouth, the basket is covered by fabric, and the mouth of the basket is uncovered.
[Embodiment Section 38]
38. A repair instrument according to any one of embodiments 31-37, wherein the front portion of the baffle has a convex shape.
[Embodiment Section 39]
The rear portion of the baffle engages and displaces the central scallop of the three scalloped anterior or posterior mitral leaflet, while the remaining two scallops 39. A repair device according to any one of embodiments 31 to 38, wherein the repair device is dimensioned to remain movable.
[Embodiment section 40]
40. The repair instrument of any one of embodiments 31-39, wherein the rear portion of the baffle is dimensioned to engage and displace the entire natural cusp.
[Embodiment section 41]
The atrial fixation member has a semicircular ring extending in a first plane, and the baffle extends in a second plane parallel to and perpendicularly offset from the first plane. 41. The repair instrument according to any one of embodiments 31-40, wherein
[Embodiment section 42]
32. The repair device of embodiment 31, wherein the forward portion of the baffle is comprised of biocompatible foam.
[Embodiment section 43]
The repair according to any one of embodiments 31 to 41, wherein the atrial fixation member has a semicircular ring sized to surround the periphery of the annulus between the anterolateral commissure and the posteromedial commissure. utensils.
[Embodiment section 44]
A heart valve repair device,
having an atrial fixation member with a central lumen;
at least one anchoring mechanism selected from the group of triangular anchor systems and rear hooks;
The triangular anchor system includes a first triangular extension attached to the atrial fixation member and extending away from the baffle, a second triangular extension attached to a second end of the partial ring and extending away from the baffle. and one of an anchor and an atraumatic tip attached to a terminal end of the first and second triangular extensions;
The posterior hook is attached to a posterior portion of the atrial fixation member, the posterior hook having a distally extending first portion and a second portion curved in a posterior direction, the posterior hook comprising: shaped to extend into the ventricles of the heart and engage the ventricular side of the natural heart valve annulus;
a baffle attached to the atrial fixation member, the baffle having an anterior portion with a smooth atraumatic surface constituting an artificial interface for one or more native cusps; and a rear portion configured to engage and displace at least a portion of the functionally defective leaflet, the baffle extending into the central lumen and displacing at least a portion of the functionally defective leaflet; The heart valve repair device approaches the closed position.
[Embodiment section 45]
45. The repair device of embodiment 44, further comprising a fabric covering at least partially surrounding the baffle.
[Embodiment section 46]
46. The repair device of embodiment 44 or 45, wherein the baffle is comprised of biocompatible foam.
[Embodiment section 47]
47. The repair device of any one of embodiments 44-46, further comprising a plurality of friction elements on a rearward portion of the atrial fixation member and the baffle.
[Embodiment Section 48]
45. The repair instrument of embodiment 44, wherein the baffle has a basket surrounding a hollow interior.
[Embodiment Section 49]
49. The repair device of embodiment 48, wherein the baffle has a plurality of front struts and a plurality of rear struts, and a gap is provided between adjacent struts of the front strut and the rear strut. .
[Embodiment section 50]
50. The repair device of embodiment 48 or 49, wherein the basket has a mouth, the basket is covered by fabric, and the mouth of the basket is uncovered.
[Embodiment Section 51]
51. The repair instrument of any one of embodiments 44-50, wherein the forward portion of the baffle has a convex shape.
[Embodiment Section 52]
The rear portion of the baffle engages and displaces the central scallop of the three scalloped anterior or posterior mitral leaflet, while the remaining two scallops 52. The repair device of any one of embodiments 44-51, wherein the repair device is dimensioned and shaped to remain movable.
[Embodiment Section 53]
53. The repair instrument of any one of embodiments 44-52, wherein the rear portion of the baffle is dimensioned to engage the entire functionally defective leaflet.
[Embodiment Section 54]
54. The atrial fixation member according to any one of embodiments 44-53, wherein the atrial fixation member has a semicircular ring sized to circumferentially surround the heart valve annulus between the anterolateral commissure and the posteromedial commissure. Repair instruments.
[Embodiment Section 55]
A heart valve repair device,
an atrial fixation member having a central lumen;
a baffle attached to the atrial fixation member, the baffle having an anterior portion with a smooth atraumatic surface defining an abutment surface for engaging one or more native cusps; and a rear portion for engaging and displacing at least a portion of the functionally defective leaflet, the baffle extending into the central lumen and providing a closure for the functionally defective leaflet. Heart valve repair instrument approaches location.
[Embodiment Section 56]
56. The heart valve repair device of embodiment 55, further comprising a fabric covering at least partially surrounding the baffle.
[Embodiment Section 57]
57. The heart valve repair device of embodiment 55 or 56, wherein the baffle is comprised of biocompatible foam.
[Embodiment Section 58]
58. The heart valve repair device of any one of embodiments 55-57, further comprising a plurality of frictional engagement elements on a rear portion of the atrial fixation device and the baffle.
[Embodiment Section 59]
59. The heart valve repair device of embodiment 55, 56, or 58, wherein the baffle comprises a basket surrounding a hollow interior.
[Embodiment Section 60]
Embodiments 55, 56, 58, wherein the baffle has a plurality of front struts and a plurality of rear struts, and gaps are provided between adjacent struts of the front struts and the rear struts. or the heart valve repair device according to 59.
[Embodiment Section 61]
60. The heart valve repair device of embodiment 55, 56, 58, or 59, wherein the basket has a mouth, the basket is covered by fabric, and the mouth of the basket is uncovered.
[Embodiment Section 62]
62. The heart valve repair device of any one of embodiments 55-61, wherein the forward portion of the baffle has a convex shape.
[Embodiment Section 63]
The rear portion of the baffle engages and displaces the central scallop of the three scalloped anterior or posterior mitral leaflet, while the remaining two scallops 63. A heart valve repair device according to any one of embodiments 55-62, wherein the heart valve repair device is dimensioned to remain mobile.
[Embodiment section 64]
The atrial fixation member includes a partially circular frusto-conical member having first and second ends and between the first end and the second end of the atrial fixation member. 64. A heart valve repair device according to any one of embodiments 55-63, wherein the heart valve repair device has a brace that extends to.
[Embodiment Section 65]
further comprising at least one fixation mechanism selected from the group of triangular anchor systems and posterior hooks, the triangular anchor being attached to the first end of the atrial fixation member and extending away from the baffle. a second triangular extension attached to the second end of the atrial fixation member and extending away from the baffle, and an anchor and terminal ends of the first and second triangular extensions; 65. A heart valve repair device according to any one of embodiments 55-64, comprising one of an atraumatic tip attached to the heart valve repair device.
[Embodiment Section 66]
A heart valve repair device for repairing a mitral valve having an anterior leaflet and a posterior leaflet, the device comprising:
an atrial anchoring member having a collapsed configuration and an expanded configuration; the atrial anchoring member having an expandable ring-shaped mesh; shaped to make contact with
a baffle extending radially inwardly from the atrial fixation member, the baffle having an outer portion configured to displace the posterior leaflet toward the ventricular wall and restrain the posterior leaflet in an open position; an inner portion having an abutment surface radially inwardly of the portion, the inner portion being spaced from the outer portion a distance such that the abutment surface is positioned at least near a closed position of the anterior leaflet; A heart valve repair device is located.
[Embodiment Section 67]
67. The heart valve repair device of embodiment 66, wherein the atrial fixation member is configured to contact only atrial wall tissue above the native annulus.
[Embodiment Section 68]
68. The heart valve repair device of embodiment 66 or 67, further comprising a biocompatible coating disposed on a surface of the baffle.
[Embodiment Section 69]
The baffle has a posterior strut extending in a downstream direction from the atrial fixation member and a anterior strut projecting inwardly and upwardly from a downstream end of the posterior strut; 69. The heart valve repair device of any one of embodiments 66-68, further comprising a covering attached to the anterior strut.
[Embodiment section 70]
70. According to any one of embodiments 66-69, the atrial fixation member has a plurality of struts, and the heart valve repair device further includes a coating attached to the struts of the atrial fixation member. Heart valve repair device.

Claims (70)

A heart valve repair device,
an atrial fixation member with an expandable mesh configured to have an oval or circular shape in a deployed configuration, the atrial fixation member having a central lumen;
a smooth atraumatic surface having a baffle extending from a portion of the atrial fixation member, the baffle being configured to mate with at least a portion of one or more native cusps of a native heart valve; and a rearward portion configured to at least partially engage and displace another native leaflet of the native heart valve, the baffle having a a repair device extending radially inwardly from the atrial fixation member into the central lumen to approximate a closed natural leaflet position; The baffle includes a strut configured in a basket having a hollow interior volume, the baffle engaging at least a first portion of the functionally defective congenital leaflet to cause the first portion to the baffle further includes a restraining portion configured to restrain a second portion of the functionally defective congenital leaflet while leaving a second portion of the functionally defective leaflet mobile; The repair instrument of claim 1, extending radially inwardly into the central lumen toward a closed position relative to the apex. The repair device of claim 1, further comprising a plurality of friction elements on portions of the atrial fixation member or the baffle. 3. The repair device of claim 2, wherein the inner and outer sides of the atrial fixation member do not include any frictional elements. 2. The repair instrument of claim 1, wherein the baffle includes a basket surrounding a hollow interior. The repair instrument of claim 1, wherein the baffle has a plurality of front struts and a plurality of rear struts, and a gap is provided between adjacent struts of the front struts and the rear struts. a fabric covering at least partially surrounding the baffle;
3. The repair instrument of claim 2, wherein the basket has an opening not covered by the fabric. a fabric covering at least partially surrounding the baffle;
3. The repair instrument of claim 2, wherein the basket has a mouth covered by the fabric. The repair device of claim 1, wherein the baffle is comprised of biocompatible foam. The repair instrument of claim 1, wherein the forward portion of the baffle has a convex shape. The posterior portion of the baffle is sized and shaped to engage the central scallop of a natural mitral leaflet having three scallops while leaving the remaining two scallops mobile. 2. The repair instrument of claim 1. further comprising a first set of suture loops disposed circumferentially around the atrial fixation member, each suture loop of the first set of suture loops defining a lumen. have,
a first suture disposed within the lumen of the suture loop and interconnecting adjacent suture loops;
The repair device of claim 1, wherein the diameter of the atrial fixation member is adjusted by tightening the first suture. further comprising a second set of suture loops disposed circumferentially around the baffle, each suture loop of the second set of suture loops having a lumen. death,
a second suture disposed within the lumen of the suture loop and interconnecting adjacent suture loops;
The repair instrument of claim 1, wherein the diameter of the baffle is adjusted by tightening the second suture. a third suture loop on the baffle;
a third suture disposed within the lumen of the third suture loop;
The repair instrument of claim 1, wherein pulling the third suture displaces the baffle. 2. The method of claim 1, further comprising at least one fabric segment of fabric attached to and at least partially spanning the atrial fixation member, wherein the fabric covering facilitates tissue ingrowth. repair instruments. The repair device of claim 1, further comprising at least one fabric segment of fabric depending from a distal end of the atrial fixation member. 17. The repair instrument of claim 16, further comprising a biasing member attached to the at least one fabric segment and biasing the fabric segment away from the central lumen. The repair device of claim 1, wherein the atrial fixation member comprises at least two rows of cells. The atrial fixation member further includes a row of chevrons;
at least two of the chevrons have through holes;
The atrial fixation member has a suture threaded through the through hole;
The repair device of claim 1, wherein tightening the suture adjusts the diameter of the atrial fixation member. The repair device of claim 1, wherein the atrial fixation member has a frusto-conical shape. 21. The repair device of claim 20, wherein the atrial fixation member is configured to engage only the atrial wall of the native heart valve. 22. The repair device of claim 21, wherein the size of the atrial fixation member unconstrained by external forces is greater than the size of the native atrium during diastole. 23. The repair device of claim 22, wherein the repair device is secured to the native heart valve only at the atrial fixation member and the baffle. The atrial fixation member has an anterior side and a posterior side, and the proximal end of the anterior side of the atrial fixation member is perpendicular to the proximal end of the posterior side of the atrial fixation member. 2. The repair instrument of claim 1, which is offset. The atrial fixation member has an asymmetric shape and the length of the anterior side of the atrial fixation member is such that the anterior side of the atrial fixation member is vertically higher than the posterior side of the atrial fixation member. The repair instrument of claim 1, wherein the length is greater than the length of the posterior side of the fixation member. The repair device of claim 1, wherein a posterior side of the atrial fixation member is stiffer than an anterior side of the atrial fixation member. The atrial fixation member has a plurality of interconnecting struts forming a plurality of cells, the struts on the posterior side of the atrial fixation member being more flexible than the struts on the anterior side of the atrial fixation member. 27. The repair instrument of claim 26, wherein the repair instrument is at least one of thicker, wider and/or with narrower gaps between adjacent struts. A method of repairing a regurgitant heart valve in a heart having an atrium with an atrial wall, a ventricle with a ventricular wall, a heart valve with at least two cusps having an open position and a closed position, the method comprising: a valve is disposed at the interface between the atrium and the ventricle, the heart has an annulus surrounding the heart valve, and the method includes:
providing a prosthetic valve leaflet device, the prosthetic valve leaflet device comprising:
an atrial fixation member made of a mesh material, the atrial fixation member comprising a central lumen configured to fluidly couple the atrium and the ventricle; the atrial fixation member includes an anterior portion, a posterior portion, a proximal portion; having a proximal end, a distal end, an inner part, and an outer part;
a baffle attached to the atrial fixation member, the anterior portion of the baffle comprising a smooth atraumatic surface acting as an artificial interface for one of the at least two cusps; a rearward portion of the at least two cusps is configured to engage and displace at least a portion of another one of the at least two cusps, and the baffle projects into the central lumen to close the displaced cusps. approach the position,
implanting the prosthetic valve leaflet device in the atrium such that the atrial anchoring member is spaced apart from the valve annulus;
A method comprising positioning the baffle against one of the at least two cusps. The atrial fixation member of the prosthetic valve leaflet device has at least two suture loops with eyelets, a suture strand threaded through the eyelet, and tightening the suture strand collapses the atrial fixation member. ,
Implanting the artificial valve leaflet device comprises:
tightening the suture strand to collapse the atrial fixation member;
positioning the prosthetic valve leaflet device with the atrial fixation member collapsed within the atrium;
29. The method of claim 28, comprising loosening the prosthetic valve leaflet device so that the atrial fixation member expands into contact with the atrial wall. 29. The method of claim 28, wherein the prosthetic leaflet device is secured to the heart valve only by the atrial anchoring member and the baffle. A heart valve repair device,
an atrial fixation member having a central lumen;
a baffle attached to the atrial fixation member, the baffle having a smooth atraumatic surface constituting an artificial coaptation surface configured to coapt with at least one native leaflet of a native heart valve. and a rearward portion configured to engage and displace at least a portion of the functionally defective leaflet, the baffle being configured to displace at least a portion of the functionally defective leaflet. A heart valve repair device extending radially inwardly into the central lumen toward a closed position. 32. The repair instrument of claim 31, further comprising a fabric covering at least partially surrounding the baffle. 32. The repair instrument of claim 31, wherein the baffle is comprised of biocompatible foam. 10. The atrial fixation device and the baffle, wherein the baffle remains in an at least substantially fixed orientation relative to the atrial fixation member. The repair instrument according to 31. 32. The repair instrument of claim 31, wherein the baffle has a basket surrounding a hollow interior. 36. The repair instrument of claim 35, wherein the baffle includes a plurality of front struts and a plurality of rear struts, with gaps between adjacent struts of the front struts and the rear struts. 36. The repair instrument of claim 35, wherein the basket has a mouth, the basket is covered by fabric, and the mouth of the basket is uncovered. 32. The repair instrument of claim 31, wherein the forward portion of the baffle has a convex shape. The rear portion of the baffle engages and displaces the central scallop of the three scalloped anterior or posterior mitral leaflet while displacing the remaining two scallops. 32. The repair instrument of claim 31, wherein the repair instrument is dimensioned and shaped to remain movable. 32. The repair instrument of claim 31, wherein the rear portion of the baffle is sized and shaped to engage and displace an entire natural cusp. The atrial fixation member has a semicircular ring extending in a first plane, and the baffle extends in a second plane parallel to and perpendicularly offset from the first plane. 32. The repair instrument of claim 31. 32. The repair instrument of claim 31, wherein the forward portion of the baffle is comprised of biocompatible foam. 32. The repair device of claim 31, wherein the atrial fixation member has a semicircular ring sized to circumferentially surround the annulus between the anterolateral and posteromedial commissures. A heart valve repair device,
having an atrial fixation member with a central lumen;
at least one anchoring mechanism selected from the group of triangular anchor systems and rear hooks;
The triangular anchor system includes a first triangular extension attached to the atrial fixation member and extending away from the baffle, a second triangular extension attached to a second end of the partial ring and extending away from the baffle. and one of an anchor and an atraumatic tip attached to a terminal end of the first and second triangular extensions;
The posterior hook is attached to a posterior portion of the atrial fixation member, the posterior hook having a distally extending first portion and a second portion curved in a posterior direction, the posterior hook comprising: configured to extend into the ventricle of the heart and engage the ventricular side of the natural heart valve annulus;
a baffle attached to the atrial fixation member, the baffle having an anterior portion with a smooth atraumatic surface constituting an artificial interface for one or more native cusps; and a rear portion configured to engage and displace at least a portion of the functionally defective leaflet, the baffle extending into the central lumen and displacing at least a portion of the functionally defective leaflet; The heart valve repair device approaches the closed position. 45. The repair instrument of claim 44, further comprising a fabric covering at least partially surrounding the baffle. 45. The repair instrument of claim 44, wherein the baffle is comprised of biocompatible foam. 45. The repair device of claim 44, further comprising a plurality of friction elements on a posterior portion of the atrial fixation member and the baffle. 45. The repair instrument of claim 44, wherein the baffle has a basket surrounding a hollow interior. 49. The repair instrument of claim 48, wherein the baffle includes a plurality of front struts and a plurality of rear struts, with gaps between adjacent struts of the front struts and the rear struts. 49. The repair instrument of claim 48, wherein the basket has a mouth, the basket is covered by fabric, and the mouth of the basket is uncovered. 45. The repair instrument of claim 44, wherein the forward portion of the baffle has a convex shape. The rear portion of the baffle engages and displaces the central scallop of the three scalloped anterior or posterior mitral leaflet while displacing the remaining two scallops. 45. The repair instrument of claim 44, wherein the repair instrument is dimensioned and shaped to remain movable. 45. The repair instrument of claim 44, wherein the rear portion of the baffle is sized and shaped to engage the entire functionally defective leaflet. 45. The repair device of claim 44, wherein the atrial fixation member includes a semicircular ring sized to circumferentially surround the heart valve annulus between the anterolateral and posteromedial commissures. A heart valve repair device,
an atrial fixation member having a central lumen;
a baffle attached to the atrial fixation member, the baffle having a smooth atraumatic surface defining an abutment surface shaped to engage one or more native cusps; and a rearward portion configured to engage and displace at least a portion of the functionally defective leaflet, the baffle extending into the central lumen and displacing the functionally defective leaflet. Heart valve repair instrument approaching the closed position for the defective leaflet. 56. The heart valve repair device of claim 55, further comprising a fabric covering at least partially surrounding the baffle. 56. The heart valve repair device of claim 55, wherein the baffle is comprised of biocompatible foam. 56. The heart valve repair device of claim 55, further comprising a plurality of frictional engagement elements on a posterior portion of the atrial fixation device and the baffle. 56. The heart valve repair device of claim 55, wherein the baffle has a basket surrounding a hollow interior. 60. The heart valve repair of claim 59, wherein the baffle has a plurality of anterior struts and a plurality of posterior struts, and gaps are provided between adjacent struts of the anterior struts and the posterior struts. utensils. 60. The heart valve repair device of claim 59, wherein the basket has a mouth, the basket is covered by fabric, and the mouth of the basket is uncovered. 56. The heart valve repair device of claim 55, wherein the forward portion of the baffle has a convex shape. The rear portion of the baffle engages and displaces the central scallop of the three scalloped anterior or posterior mitral leaflet while displacing the remaining two scallops. 56. The heart valve repair device of claim 55, wherein the heart valve repair device is dimensioned and shaped to remain mobile. The atrial fixation member includes a partially circular frusto-conical member having first and second ends and between the first end and the second end of the atrial fixation member. 56. The heart valve repair device of claim 55, further comprising: a brace extending into the heart valve repair device. further comprising at least one fixation mechanism selected from the group of triangular anchors and posterior hooks, the triangular anchor being attached to the first end of the atrial fixation member and extending away from the baffle. a second triangular extension attached to the second end of the atrial fixation member and extending away from the baffle, and an anchor and terminal ends of the first and second triangular extensions. and an atraumatic tip attached to the heart valve repair instrument. A heart valve repair device for repairing a mitral valve having an anterior leaflet and a posterior leaflet, the device comprising:
an atrial fixation member configured to have a collapsed configuration and an expanded configuration, the atrial fixation member having an expandable ring-shaped mesh, and the atrial fixation member configured to have a collapsed configuration and an expanded configuration; configured to contact tissue of the atrial wall;
a baffle extending radially inwardly from the atrial fixation member, the baffle having an outer portion configured to displace the posterior leaflet toward the ventricular wall to constrain the posterior leaflet in an open position; an inner portion having an abutment surface radially inwardly of the portion, said inner portion being spaced from said outer portion a distance such that said abutment surface is positioned at least near a closed position of said anterior leaflet; A heart valve repair device is located. 67. The heart valve repair device of claim 66, wherein the atrial fixation member is configured to contact only atrial wall tissue above the native annulus. 67. The heart valve repair device of claim 66, further comprising a biocompatible coating disposed on a surface of the baffle. The baffle has a posterior strut extending in a downstream direction from the atrial fixation member and a anterior strut projecting inwardly and upwardly from a downstream end of the posterior strut; 67. The heart valve repair device of claim 66, further comprising a covering attached to the anterior strut. 67. The heart valve repair device of claim 66, wherein the atrial fixation member has a plurality of struts, and the heart valve repair device further includes a covering attached to the struts of the atrial fixation member.